NCT03692598 Study of Transcatheter Tricuspid Annular Repair
| NCT ID | NCT03692598 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Micro Interventional Devices |
| Condition | Tricuspid Regurgitation |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2016-12 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2016-12 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of the study is to evaluate the safety and performance of the MIA Minimally Invasive Annuloplasty Device in patients with chronic functional tricuspid regurgitation.
Eligibility Criteria
Inclusion Criteria: 1. Chronic functional tricuspid regurgitation (FTR) with a minimum of moderate tricuspid regurgitation (2-4) 2. Age≥18 and ≤85 years old 3. New York Heart Association (NYHA) Class II, III or ambulatory IV 4. Left ventricular ejection fraction (LVEF) ≥30% 5. Undergoing cardiac surgical procedure with the planned use of cardiopulmonary bypass (surgical arm only) 6. Functional tricuspid valve regurgitation pathology with a structurally normal valve; and tricuspid valve annular diameter ≥ 40 mm (or 21 mm/m2) and ≤55 mm (or 29 mm/m2) or 2-4 + FTR 7. Patient provides written Informed Consent before any study-specific tests or procedures are performed 8. Patient is willing and able to comply with all specified study evaluations Exclusion Criteria: 1. Pregnant or lactating female 2. Severe uncontrolled hypertension (SBP ≥ 180 mmHg and/or DBP ≥ 110 mmHg) 3. Previous tricuspid valve repair or replacement 4. Myocardial Infarction or known unstable angina within the 30-days prior to the index procedure 5. Any PCI within 30 days prior to the index procedure or planned 3 months post the index procedure 6. Life expectancy of less than 12-months 7. Severe right heart dysfunction 8. Pulmonary hypertension with PA mean 2/3 rd MAP 9. Active systemic infection 10. Pericardial infection 11. Any clinical evidence that the investigator feels would place the patient at increased risk with the deployment of the device 12. Co-morbid conditions that place the subject at an unacceptable surgical risk (e.g. severe chronic obstructive pulmonary disease, hepatic failure, cardiac disease, autoimmune disorders or conditions of severe immunosuppression) 13. Untreated coronary artery disease (CAD) requiring revascularisation unless CABG procedure is concomitant with MIA tricuspid annular repair (surgical arm only) 14. Haemodynamic instability: systolic blood pressure \<90mmHg without reduction of afterload, shock, need for inotropic medication or IABP 15. Active peptic ulcer or gastrointestinal (GI) bleeding in the past 3 months 16. Cerebrovascular event within the past 6 months 17. History of mitral/tricuspid endocarditis within the last 12 months 18. Organic tricuspid disease 19. Contraindication or known allergy to device's components, aspirin, anti-coagulation therapy or contrast media that cannot be adequately premeditated 20. Known alcohol or drug abuser 21. Currently participating in the study of an investigational drug or device
Contact & Investigator
Angie Swenson
✉ aswenson@microinterventional.comKestutis Rucinskas, MD
PRINCIPAL INVESTIGATOR
Vilnius University Hospital, Santariskiu Klinikos
Frequently Asked Questions
Who can join the NCT03692598 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Tricuspid Regurgitation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03692598 currently recruiting?
Yes, NCT03692598 is actively recruiting participants. Contact the research team at aswenson@microinterventional.com for enrollment information.
Where is the NCT03692598 trial being conducted?
This trial is being conducted at Aarhus, Denmark, Budapest, Hungary, Riga, Latvia, Kaunas, Lithuania and 2 additional locations.
Who is sponsoring the NCT03692598 clinical trial?
NCT03692598 is sponsored by Micro Interventional Devices. The principal investigator is Kestutis Rucinskas, MD at Vilnius University Hospital, Santariskiu Klinikos. The trial plans to enroll 60 participants.